Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia

Inclusion Criteria:

confirmed CLL diagnosis and active CLL requiring treatment
considered inappropriate for fludarabine-based therapy
not been treated for CLL before
fully active at a minimum or fully capable of selfcare and up and about more than 50% of waking hours
age 18yrs or older
signed written informed consent

Exclusion Criteria:

prior CLL therapy
abnormal/inadequate blood values, liver, and kidney function
certain heart problems, active or chronic infections, serious significant diseases, active autoimmune hemolytic anemia (AIHA) requiring treatment, other current cancer or within last 5 years
CLL transformation
CLL central nervous system involvement
current participation in other clinical study
inability to comply with the protocol activities
lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception